FDA Sounds Alarm About Risks of Fluid-Filled Intragastric Balloons
The FDA has received multiple reports for two different types of adverse events associated with fluid-filled intragastric balloons used to treat obesity.
Intragastric balloon systems are weight-loss systems to treat obesity, which function by taking up space in a patient’s stomach.
The first type of adverse event involves the fluid-filled intragastric balloon over-inflating with air or with more fluid in patients’ stomachs, resulting in the need for premature device removal. The second type of adverse event is the development of acute pancreatitis, which has also resulted in the need for premature device removal.
Although the root cause and incidence of these complications are unknown, healthcare providers are encouraged to be aware of these potential adverse events should patients report discomfort. Should the device be removed, providers should follow the manufacturer’s instructions for device returns or evaluations.
EU Awards CE Marking to Pressure BioSciences’ Sample Preparation Instrument
Pressure BioSciences has earned the CE Mark for the Barocycler 2320EXTREME device, which uses pressure cycling to separate components of blood and other fluids.
The device includes data logging options, user-level security, touch screen programming and the ability to customize multiple pressure cycling parameters.
FDA Awards OTC Clearance for Drug-free Musculoskeletal Pain Therapy
Frederick, Maryland–based, BioElectronics gained over-the-counter use FDA market clearance for ActiPatch for the adjunctive treatment of musculoskeletal pain related to plantar fasciitis of the heel and osteoarthritis of the knee.
The device uses low power pulse electromagnetic fields to regulate electrical activity in the nervous system.
Bioness Gains FDA Clearance for the L300 Go System
Valencia, California–based, Bioness received marketing clearance from the FDA for the L300 Go System.
The device provides 3D motion detection of gait and includes a mobile application to track user activity. The system delivers electrical stimulation and uses data from a 3-axis gyroscope and accelerometer.
Patient movement is monitored in all three planes and stimulation is deployed when needed during the gait cycle. An adaptive algorithm accommodates changes in gait dynamics and a high speed processor deploys stimulation within 10 milliseconds of detecting a valid gait event.
FDA Clears Inova Diagnotics’ Assays
San Diego–based, Inova Diagnostics has won FDA marketing clearance for its NOVA Lite DAPI ANCA (ethanol) and NOVA Lite DAPI ANCA (formalin) kits for use with NOVA View, a digital IFA (immunofluorescence assay) microscope.
The kits are reagents for the detection of anti-neutrophil cytoplasmic antibodies.